FDAnews Device Daily Bulletin

MILLENIUM BIOLOGIX ANNOUNCES FDA 510(K) CLEARANCE FOR FIRST DEVICE BASED ON MICROPOROUS SKELITE TECHNOLOGY

Nov. 23, 2005
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Millenium Biologix recently announced that it has received a Class II 510(k) clearance from the U.S. Food and Drug Administration ("FDA") to market and sell its Microporous Skelite Resorbable Cement Restrictor product in the United States. "This clearance allows us to bring our first product to market based on our Microporous Skelite Technology," said Dr. Timothy Smith, President and COO of Millenium. "This Microporous Skelite Technology enables the development of specialized synthetic bone graft implants with greater compressive strength and impact resistance. With these enhanced properties, the range of orthopedic applications for our Skelite technology has been broadened to include those where higher stresses are involved."

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